Deep rTMS for Mild Neurocognitive Disorder in Older Adults

NCT07038798 | Recruiting

• 1 other identifier: 18440
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to: (1) assess the feasibility and tolerability of three deep transcranial magnetic stimulation (dTMS) coils H1, H4, and H7 in older adults with mild neurocognitive disorder (mild NCD); and (2) evaluate changes in cognition through neuropsychological testing, brain activity through EEG, and mood and sleep through self-report questionnaires. Participants will be assigned to one of three arms: H1- coil vs. H4-coil vs. H7-coil, and all participants will complete assessments examining dTMS side effects, mental health symptoms, and cognition. EEG, questionnaires, and CNS vital signs will be measured at baseline, midpoint (after 10th session- before dTMS treatment on visit 11), and end point, as well as follow up. Collectively, the study will address the absolute and differential feasibility and tolerability of the H1, H4 and H7 coils to provide preliminary data for a future randomized controlled trial comparing this novel intervention to a sham stimulation (placebo) control.

Conditions

Mild Neurocognitive Disorder

Keywords

Mild Neurocognitive Disorder; Mild NCD; Mild Cognitive Impairment; Deep Transcranial Magnetic Stimulation; deep TMS; dTMS; H coil; H-coil; H1-coil; H4-coil; H7-coil

Outcome Measures

Primary Outcomes (7)

• Feasibility criteria 1: Protocol completion

  Percentage of intervention sessions completed

  6 weeks

• Feasibility criteria 2: Retention rate

  Percentage of participants who complete study once enrolled

  6 weeks

• Feasibility criteria 3: Screening rates and capacity

  Number of participants (n) screened; n enrolled as a percentage of n screened monthly

  6 weeks

• Feasibility criteria 4: Recruitment rate and capacity

  Total number of participants recruited and enrolled per month.

  6 weeks

• Feasibility criteria 5: Duration of intervention and assessment processes

  Compared to estimated times, the actual mean times (in min) from start to finish for each dTMS intervention session and mean time (in hours) from start to finish for each visit.

  6 weeks

• Feasibility criteria 6: Safety of H-coil dTMS treatment

  Total number of adverse events reported during the treatment sessions assessed by the Side Effects Questionnaire for dTMS (custom-developed for study). At each dTMS stimulation session, participants will complete a questionnaire to evaluate potential adverse effects of dTMS (headache, neck pain, itching and redness at the site of stimulation) according to a 4-point scale.

  6 weeks

• Tolerability of H-coil dTMS treatment

  Percentage of participants withdrawn or terminated following enrollment due to adverse events

  6 weeks

Secondary Outcomes (12)

• Changes from baseline on the Everyday Memory Questionnaire (EMQ)

  6 weeks + one-month follow-up

• Changes from baseline in Neurocognitive Performance measured by the CNS Vital Signs Test Battery

  6 weeks + one-month follow-up

• Change from baseline on the Hamilton Depression Rating Scale- 24 item (HDRS-24).

  6 weeks + one-month follow-up

• Change from baseline on the General Anxiety Disorder- 7 item (GAD-7)

  6 weeks + one-month follow-up

• Change from baseline on the Pittsburgh Sleeping Quality Index (PSQI)

  6 weeks + one-month follow-up

Study Arms (3)

Active H1-coil dTMS treatment

EXPERIMENTAL

This arm will receive dTMS treatment through active H1-coil.

Device: Brainsway H1-Coil Deep TMS System

Active H4-coil dTMS treatment

EXPERIMENTAL

This arm will receive dTMS treatment through active H4-coil.

Device: Brainsway H4-Coil Deep TMS System

Active H7-coil dTMS treatment

EXPERIMENTAL

This arm will receive dTMS treatment through active H7-coil.

Device: Brainsway H7-Coil Deep TMS System

Interventions

Brainsway H1-Coil Deep TMS System DEVICE

Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H1-coil.

Active H1-coil dTMS treatment

Brainsway H4-Coil Deep TMS System DEVICE

Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H4-coil.

Active H4-coil dTMS treatment

Brainsway H7-Coil Deep TMS System DEVICE

Participants assigned to this arm will complete a 6-week course of 20 dTMS stimulation session using the Brainsway H7-coil.

Active H7-coil dTMS treatment

Eligibility Criteria

• Age: 60 Years - 90 Years
• Gender Eligibility Details: We will implement a sex equity approach by aiming at a 50/50% rate of male and female but allowing an imbalance of maximum 70/30% from either side.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Able to provide informed consent to participate in the study
• Subjective concern of mild decline in cognitive function over the past year
• Mild impairment in cognitive performance
• Preserved independence in everyday activities
• Independently mobile (e.g., participants must be able to get in and out of a chair on their own)
• Participants will be required to be on stable dosages of other psychotropic medications for at least 4 weeks prior to screening

You may not qualify if:

• Currently receiving treatment or subjective need for treatment for bipolar I or II disorder; psychotic disorder
• Active suicidal behavior
• Severe depression and/or anxiety
• Other neurological or psychiatric disorders accounting for the cognitive deficits
• Impairment in basic and/or instrumental activities of daily living
• Substance use disorder (other than tobacco use disorder) in the past 3 months before entering the study
• Traditional contraindications to rTMS: Intracranial or metal implants in the head or nearby regions, excluding the mouth, that cannot be safely removed; History of epilepsy or seizures; Active unstable medical condition (recent laboratory and neuroimaging alterations, delirium); Pacemaker and/or implantable cardioverter-defibrillators; current use of bupropion, treatment with equivalent benzodiazepine dose to lorazepam \>2 mg/day
• People with severe literacy, visual, or hearing issues that affect the ability to engage in the interviews
• People with recurring migraines or headaches (weekly or more)
• Frequent dizziness/vertigo
• Individuals residing beyond the borders of the Greater Hamilton Area and its neighbouring vicinities

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

Peter Boris Centre for Addictions Research, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L9C 0E3, Canada

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Only study staff processing and analyzing the data will be fully blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One way three-group between-subjects open-label, parallel-arm design

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 26, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-05

Locations

CA (1)